MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-03-12 for VERTECEM V+ SYRINGE KIT 03.702.215S manufactured by Oberdorf Synthes Produktions Gmbh.
[138769875]
(b)(6). Device history lot: part: 03. 702. 215s; lot:8102588; manufacturing site: (b)(4); supplier: (b)(4); release to warehouse date: 16 dec 2018; expiry date: 01. Oct 2023. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified. Investigation summary: picture review: narrative could be confirmed from provided pictures. It is visible that the tip, e. G. The luer lock of the syringe is missing/broken off. Product was not returned. However, the information about this occurrence was forwarded to the supplier. Supplier statement will be documented in complaint (b)(4) (same event description, same part/lot number). Based on the information available, it has been determined that no corrective and/or preventive action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[138769876]
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, during an unknown procedure, the tip of the blue vertecem syringe (1ml) broke while removing from cement reservoir (vercetem v+cement kit). Other syringes had no issues and could be used to finish the procedure. The surgical procedure was successfully completed. There was no surgical delayed and patient consequence reported. Concomitant device reported: vercetem v+cement kit (part# 07. 702. 016s, lot# unknown, quantity 1). This complaint involves one (1) device. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2019-61911 |
| MDR Report Key | 8414868 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-12 |
| Date of Report | 2019-02-18 |
| Date of Event | 2019-02-18 |
| Date Mfgr Received | 2019-04-08 |
| Device Manufacturer Date | 2018-12-16 |
| Date Added to Maude | 2019-03-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | EIMATTSTRASSE 3 |
| Manufacturer City | OBERDORF 4436 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 4436 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | SYNTHES SELZACH |
| Manufacturer Street | BOHACKERWEG 5 |
| Manufacturer City | SELZACH 2545 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 2545 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERTECEM V+ SYRINGE KIT |
| Generic Name | CEMENT DISPENSER |
| Product Code | OAR |
| Date Received | 2019-03-12 |
| Catalog Number | 03.702.215S |
| Lot Number | 8102588 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OBERDORF SYNTHES PRODUKTIONS GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-12 |